Exosome-mediated diagnosis of hepatitis virus infections and diseases

A method for monitoring the course of hepatitis virus infection or a hepatitis disease condition in a subject, comprising:

• (a) obtaining first and second urine samples from the subject at first and second time points;
• (b) isolating exosomes from said first and second urine samples thereby forming first and second exosome preparations therefrom;
• (c) extracting proteins from each of said first and second exosome preparations thereby forming first and second extracted protein preparations;
• (d) contacting each of the first and second extracted protein preparations with an antibody directed against at least one HBV protein or at least one HCV protein;
• and
• (e) measuring the level of the at least one HBV protein or the at least one HCV protein in the first extracted protein preparation obtained at the first time point;
• (f) measuring the level of the at least one HBV protein or the at least one HCV protein in the second extracted protein preparation obtained at the second time point;
• (g) comparing the level of the at least one HBV protein or the at least one HCV protein in the first extracted protein preparation to the level of the at least one HBV protein or the at least one HCV protein in the second extracted protein preparation;
• and
• (h) determining the disease progression between the first time point and the second time point based on the result of step (g),
• wherein the antibody directed against the at least one HBV protein is directed against an HBV protein selected from the group consisting of HBV core antigen (HBcAg), HBV surface antigen (HBsAg), HBV e antigen (HBeAg), HBV X protein (HBx), HBV polymerase, HBV envelope protein S, HBV envelope protein, HBV envelope protein L, and combination thereof, and
• wherein the antibody directed against the at least one HCV protein is directed against an HCV protein selected from the group consisting of HCV core antigen (HCVcAg), HCV C protein, HCV E1 protein, HCV E2 protein, HCV p7 protein, HCV NS2 protein, HCV NS3 protein, HCV NS4a protein, HCV NS4b protein, HCV NS5a protein, HCV NS5b protein, and combination thereof.

A method for monitoring the effectiveness of treatment to a subject with an anti-hepatitis virus agent, comprising:

• (a) administering an anti-HBV or anti-HCV virus agent to the subject and obtaining first and second urine samples from the subject at first and second time points relative to said administration;
• (b) isolating exosomes from said first and second urine samples thereby forming first and second exosome preparations therefrom;
• (c) extracting proteins from each of said first and second exosome preparations thereby forming first and second extracted protein preparations;
• (d) contacting each of the first and second extracted protein preparations with an antibody directed against at least one HBV protein or at least one HCV protein;
• and
• (e) measuring the level of the at least one HBV protein or the at least one HCV protein in the first extracted protein preparation obtained at the first time point;
• (f) measuring the level of the at least one HBV protein, or the at least one HCV protein in the second extracted protein preparation obtained at the second time point;
• (g) comparing the level of the at least one HBV protein or the at least one HCV protein in the first extracted protein preparation to the level of the at least one HBV protein or the at least one HCV protein in the second extracted protein preparation;
• and
• (h) determining the effectiveness of treatment with the anti-HBV or anti-HCV virus agent based on the result of step (g),
• wherein the antibody directed against the at least one HBV rotein is directed against an HBV protein selected from the group consisting of HBV core antigen (HBcAg), HBV surface antigen (HBsAg), HBV e antigen (HBeAg), HBV X protein (HBx), HBV polymerase, HBV envelope protein S, HBV envelope protein, HBV envelope protein L, and combination thereof, and
• wherein the antibody directed against the at least one HCV protein is directed against an HCV protein selected from the group consisting of HCV core antigen (HCVcAg), HCV C protein, HCV E1 protein, HCV E2 protein, HCV p7 protein, HCV NS2 protein, HCV NS3 protein, HCV NS4a protein, HCV NS4b protein, HCV NS5a protein, HCV NS5b protein, and combination thereof.